An issue about the efficacy for the time-to-event outcome based on accelerated failure time model with interaction of unrecognized heterogeneity and main effect

The accelerated failure time model is an alternative method to deal with survival data if the proportional hazard model fails to capture the relationship between the hazard time and covariates. That is, the proportionality assumption is not suitable to analyze survival data. In this paper, we address the issue that the relationship between the hazard time and the main effect with unrecognized heterogeneity which interacts with main effect is satisfied with the accelerated failure time model to design a trial. The test statistic for the main effect is used to determine the total sample size for a trial and the proposed criteria are used to rationalize partition sample size.